Nobel Biocare's Procera® Abutment Brånemark is indicated for the treatment of partially edentulous patients requiring a prosthetic device. In addition to the Brånemark implant, the abutment's hexagon connector fits the external hexagon of the following endosseous implants:

3i® 3.75
Lifecore® Biomedical Restore 3.75
Zimmer® Dental Taperlock 4.0
Sterngold Implamed® 3.75

Device Description

The Procera® Abutment Brânemark is an artificial tooth abutment designed to fit and function on root-form endosseous implants having an external hexagon abutment interface.
Nobel Biocare's Procera® Abutment Brånemark is intended for use in the treatment of partially edentulous patients in arder to restore chewing function. The Procera® Abutment Brånemark is a prosthetic device panonto in brace's Brånemark external hexagon endosseous implant as well as the endosseous implants specifically indicated. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Brånemark can be made from titanium, alumina, or zirconia.

AI/ML Overview

The provided text is a 510(k) summary for the Nobel Biocare Procera® Abutment Brånemark. It details the device description, indications for use, and a statement that "The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and The Class II Special Controls Guidance Document: Root Porn Lindoseous Beach (May 12, 2004) was identified as applicable to this submission."

However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document is a regulatory submission for a dental implant abutment, focused on demonstrating substantial equivalence to previously marketed devices. It does not include the type of performance study details requested in your prompt.

Summary

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OCT 2 0 2004

K042658

510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Elizabeth J. MasonSr. Regulatory Affairs Specialist
Address:	Nobel Biocare USA LLC.22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800, ext. 7830
Facsimile:	(714) 998-9348
Date of Submission:	September 24, 2004
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Trade or Proprietaryor Model Name:	Procera® Abutment Brånemark
Legally Marketed Device(s):	Esthetic Zirconia Abutment (K031719)Procera® Abutment System (K974150)Ceramic Abutment (K913255)3i Dental Abutment (K032263)Restore Self-Tapping Dental Implant System (K954512)Taperlock Dental Implant System (K011038)Sterngold ImplaMed Hex Implant (K981516)

Device Description:

The Procera® Abutment Brânemark is an artificial tooth abutment designed to fit and function on root-form endosseous implants having an external hexagon abutment interface.

Nobel Biocare's Procera® Abutment Brånemark is intended for use in the treatment of partially edentulous patients in arder to restore chewing function. The Procera® Abutment Brånemark is a prosthetic device panonto in brace's Brånemark external hexagon endosseous implant as well as the endosseous implants specifically indicated. The device has been developed for long-term, permanent use.

Nobel Biocare's Procera® Abutment Brånemark can be made from titanium, alumina, or zirconia.

Indications for Use:

- 316 3.75

Lifecore® Biomedical Restore 3.75
Zimmer® Dental Taperlock 4.0
Sterngold Implamed® 3.75

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Performance Standards 1.5

The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and The Class II Special Controls Guidance Document: Root Porn Lindoseous Beach (May 12, 2004) was identified as applicable to this submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three horizontal lines extending from its head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K042658

K042038
Trade/Device Name: Procera® Abuttment Brånemark
Trade/Device Name: Procera® Abutese Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment
Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 24, 2004 Received: October 4, 2004

Dear Ms. Mason:

We have reviewed your Section 510(k) premarket notification of intent to market the device
tion the We have reviewed your Section 710(ts) premaited is substantially equivalent (for the referenced above and have detembled the use its marketed predicate devices marketed in
indications for use stated in the enclosure in degally marketed in indications for use stated in the checksates to the enactment date of the Medical Device interstate commerce pror to way 20, 1770, the cardance with the provisions of
Amendments, or to devices that have been recogner approval of a premarket Amendments, or to devices that have been for that do not require approval of a prematice
the Federal Food, Drug, and Cosmetic Act (Act) that do not require subject to the gen the Federal Food, Drug, and Cosmette Act (res) and at the device, subject to the general
approval application (PMA). You may, therefore, market the Act include approval application (1 Mrx). "Tod ina)y movisions of the Act include and controls provisions of the Act. "The gentina occurses, good manufacturing practice, the succession requirements for anilud reagainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into controls. Existing major regulations affecting (PMA), it may be subject to such additional vonitors. Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, Farts 800 to 898. your device can be found in the Code of Peachards, we games of the Federal Register.

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Page 2 - Ms. Mason

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements mean that FDA has made a decermination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally receit statutes and regaranents, including, but not limited to: registration You must comply with an the Hec b required (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceming (21 cms (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by seatly by seems (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-542 of t 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organ mading of substantial equivalence of your device to a premarket notification. The PDF missis in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), . If you desire specific at not compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chin Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Procera® Abutment Brånemark

Indications For Use:

Nobel Biocare's Procera® Abutment Brånemark is indicated for the treatment of partially Nobel Diocare 91 rocera in addition to the Brånemark implant, edentulous patibility requiring " "The external hexagon of the following endosseous implants:

3i® 3.75
Lifecore® Biomedical Restore 3.75
Zimmer® Dental Taperlock 4.0
Sterngold Implamed® 3.75

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Runne

(Division Sign-Off) Division of Anesthesiology, General Hospita Infection Control, Dental Devices

510(k) Number ..

Page 1 of 1

000007

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)